Most Ethics Boards Permit Docs “Finder’s Fees”
From the American Medical Association’s American Medical News: Most IRB rules don’t ban finder’s fees for clinical trials
The American Medical Association, the American College of Physicians and others have declared unethical the practice of paying doctors “finder’s fees” for recruiting patients as clinical research subjects. But only half of institutional review boards address in writing the conflict of interest these kinds of payment incentives pose, according to a survey of IRB policies at 117 medical schools that received National Institutes of Health research funding.
Interestingly, many ethics review boards don’t explicitly ask about these kinds of (very common) finder’s fees. Most ethics review forms and processes inquire about potential “conflicts of interest” as well as inclusion and exclusion criteria, but one can easily see how a researcher might make a plausible case that a finder’s fee, per se, doesn’t fit in any of the above categories. Some might say, well, it’s not a conflict of interest, it’s a fee for the time and energy it takes to screen, consent, collect data and follow up with participants. Furthermore, most ethics review forms simply ask for researchers to list inclusion and exclusion criteria. These kinds of fees aren’t part of an inclusion criteria — they relate to the researcher, not the participants’ characteristics. Finder’s fees are clearly the result of a patient meeting the inclusion criteria and providing consent. This then means that these fees create a situation of conflict of interest. Remember, a COI is just a situation where someone (the clinical researcher in this case) is expected to exercise judgment on behalf of others, and has some “other” interest (e.g., getting a finder’s fee) that stands to bias his or her judgment.
It’s not all about physician-researchers either. Most large clinical studies employ research assistants or research nurses to manage the study by finding patients who are eligible, carrying out the consent process, collecting data and following up with patient participants. These research assistants often get a finder’s fee (perhaps a hundred dollars per patient) in addition to their usually fairly modest salaries…
Ethics review boards take care to advise researchers about separating the recruitment phase from the consent phase of a study. This is done in order to allow persons who meet the inclusion criteria for a study to consider their potential participation and avoid the undue pressure or coercion that might be part of a too-quick process. They also take care to, in some kinds of research, ensure that the person recruiting and taking consent is not someone who is, for example, in a position of power over the potential participant — like their boss or professor, for example. These kinds of recommendations are made by ethics review boards in order to protect participants from things like coercion, undue influence or pressure to participate in a study. In other words, these strategies protect the voluntary nature of participation at the very vulnerable points of first contact, recruitment and consent.
If these kinds of strategies are being highly recommended by most conscientious ethics review boards, why would we also not have an explicit question on every ethics review form about whether or not money will be paid per participant successfully enrolled? It seems straightforward to me, as money is much more likely to influence the voluntariness of the recruitment and consent phases by perhaps making researchers (even unconsciously) apply pressure to participate, downplay risk or burden, overemphasize potential benefits or use techniques to convince people to sign up for the study. All the strategies I’ve outlined above, for protecting participants’ right to participate voluntarily, are much less meaningful when there’s money — for participation — on the line.
For more on the original study, see IRB: Ethics & Human Research Jan/Feb 2009 issue
NOTE: due to a technical error, this posting shows up as having been authored by Chris MacDonald. It was in fact authored by Nancy Walton.